What is it about?

This study examined the safety and impact on tissue and circulating immune cell populations of sub-urothelial injection of durvalumab in patients with non-metastatic muscle-invasive bladder cancer or non-muscle-invasive bladder cancer planned for radical cystectomy. The study found that sub-urothelial injection of 150 mg durvalumab is feasible and safe without associated immune-related adverse events. The study also showed that immune populations changed following durvalumab injection, suggesting establishment of a local immunological response. The study concludes that further studies utilizing this therapeutic modality should be pursued based on its tolerability, safety, potential efficacy, and the unmet need for effective treatment options in NMIBC.

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Why is it important?

This research is important because it examines the safety and feasibility of sub-urothelial injection of durvalumab, a PD-L1 inhibitor, in patients with non-muscle-invasive bladder cancer or non-muscle-invasive bladder cancer planned for radical cystectomy. The study is significant because it shows that sub-urothelial injection of 150 mg durvalumab is safe and tolerable without associated immune-related adverse events. Moreover, the research demonstrates local immunological effects following durvalumab injection, which suggests the establishment of a local immune response. Given the success of systemic immune checkpoint inhibitors (ICIs) in advanced urothelial cancer, this treatment modality holds promise for effective treatment options in non-muscle-invasive bladder cancer, which currently has limited treatment options. Key Takeaways: 1. Sub-urothelial injection of 150 mg durvalumab is safe and tolerable without associated immune-related adverse events. 2. The study shows local immunological effects following durvalumab injection, which suggests the establishment of a local immune response. 3. This treatment modality holds promise for effective treatment options in non-muscle-invasive bladder cancer, which currently has limited treatment options.

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This page is a summary of: The SUB‐urothelial DUrvalumab InjEction‐1 (SUBDUE‐1) trial: first‐in‐human trial in patients with bladder cancer, BJU International, March 2024, Wiley,
DOI: 10.1111/bju.16325.
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